II. Determine the disease-free survival of patients treated with this drug. III. Determine
the pharmacokinetics of this drug in these patients. IV. Determine the toxic effects of this
drug in these patients. V. Determine the rates of hematological, cytogenetic, and molecular
response and time to response in patients treated with this drug.

OUTLINE: This is a multicenter study. Patients are stratified according to disease (chronic
myelogenous leukemia [CML] in first chronic phase after failing interferon therapy or
demonstrating intolerance to interferon [closed to accrual as of 12/05/03] vs CML relapsing
after stem cell transplantation or in second or subsequent chronic phase [closed to accrual
as of 7/29/05] vs newly diagnosed CML in first chronic phase with no prior treatment [closed
to accrual as of 7/29/05] vs newly diagnosed CML in first chronic phase with no prior
treatment).

Patients receive oral imatinib mesylate once daily on days 1-28. Courses repeat every 28
days for 1 year in the absence of disease progression or unacceptable toxicity. Patients who
fail to achieve a complete hematologic response after 3 courses or a partial or complete
cytogenic response after 6 courses are removed from the study.

PROJECTED ACCRUAL: A total of 109 patients (30 for stratum I [closed to accrual as of
12/05/03] and stratum II [closed to accrual as of 7/29/05], 34 for stratum III [closed to
accrual as of 7/29/05], and 45 for stratum IV) will be accrued for this study within 2
years.

- Intolerance to interferon therapy defined as more than two grade 2 toxic effects
or any grade 3 toxic effect related to interferon therapy, except grade 3 fever,
that is persistent beyond the first 28-day course of therapy and unresponsive to
standard supportive care interventions

- Stratum II (closed to accrual as of 7/29/05): CML recurring after stem cell
transplantation or in second or subsequent chronic phase

- No prior immunotherapy (for patients in stratum III [closed to accrual as of 7/29/05]
and stratum IV only)

- At least 3 months since prior stem cell transplantation (SCT) (patients with
allogeneic SCT must have no active graft-versus-host disease [GVHD] and have stable
use of steroids) (for patients in stratum II only )

- At least 1 week since prior growth factors

- At least 1 week since prior biologic therapy, including interferon alfa (for patients
in stratum I [closed to accrual as of 12/05/03] and stratum II only)

- Recovered from prior immunotherapy

- No concurrent immunomodulating agents

- See Disease Characteristics

- No prior chemotherapy (for patients in stratum III [closed to accrual as of 7/29/05]
and stratum IV only)

- At least 6 weeks since prior busulfan or nitrosoureas

- At least 7 days since prior hydroxyurea

- At least 7 days since prior low-dose cytarabine (less than 30 mg/m^2 every 12 to 24
hours)

- At least 14 days since prior moderate-dose cytarabine (100-200 mg/m^2 for 5 to 7
days)

- At least 28 days since prior high-dose cytarabine (1-3 g/m^2 every 12 to 24 hours for
6 to 12 doses)

- At least 21 days since all other cytotoxic chemotherapy

- Recovered from prior chemotherapy

- No concurrent chemotherapy

- No concurrent steroids other than for controlled GVHD in patients with prior
allogeneic SCT

- No prior radiotherapy (for patients in stratum III [closed to accrual as of 7/29/05]
and stratum IV only)

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